# Inferential methods for functional data from wearable devices

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $298,890

## Abstract

Project Summary/Abstract
This is a project to develop new statistical methods for comparing groups of subjects in terms of health outcomes
that are assessed using data from wearable devices. Inexpensive wearable sensors for health monitoring are now
capable of generating massive amounts of data collected longitudinally, up to months at a time. The project will
develop inferential methods that can deal with the complexity of such data. A serious challenge is the presence
of unmeasured time-dependent confounders (e.g., circadian and dietary patterns), making direct comparisons or
borrowing strength across subjects untenable unless the studies are carried out in controlled experimental con-
ditions. Generic data mining and machine learning tools have been widely used to provide predictions of health
status from such data. However, such tools cannot be used for signiﬁcance testing of covariate effects, which is
necessary for designing precision medicine interventions, for example, without taking the inherent model selection
or the presence of the unmeasured confounders into account. To overcome these difﬁculties, a systematic de-
velopment of inferential methods for functional outcome data obtained from wearable devices will be carried out.
There are three speciﬁc aims: 1) Develop metrics for functional outcome data from wearable devices, 2) Develop
nonparametric estimation and testing methods for activity proﬁles and a screening method for predictors of activity
proﬁles, 3) Implement the methods in an R package and carry out two case studies using accelerometer data. For
Aim 1, the approach is to reduce the sensor data to occupation time proﬁles (e.g., as a function of activity level),
and formulate the statistical modeling in terms of these proﬁles using survival and functional data analytic meth-
ods. This will have a number of advantages, the principal one being that time-dependent confounders become
less problematic because the effect of differences in temporal alignment across subjects is mitigated. In addition,
survival analysis methods can be applied by viewing the occupation time as a time-to-event outcome indexed by
activity level. For Aim 2, nonparametric methods will be used to compare and order occupation time distributions
between groups of subjects that are speciﬁed in terms of baseline covariate levels or treatment groups. Further,
a new method of post-selection inference based on marginal screening for function-on-scalar regression will be
developed to identify and formally test whether covariates are signiﬁcantly associated with activity proﬁles. Aim
3 will develop an R-package implementation, and as a test-bed for the proposed methods they will be applied to
two Columbia-based clinical studies: to the study of physical activity in children enrolled in New York City Head
Start, and to the study of experimental drugs for the treatment of mitochondrial depletion syndrome.

## Key facts

- **NIH application ID:** 10394221
- **Project number:** 5R01AG062401-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** IAN WRAY MCKEAGUE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $298,890
- **Award type:** 5
- **Project period:** 2019-04-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10394221

## Citation

> US National Institutes of Health, RePORTER application 10394221, Inferential methods for functional data from wearable devices (5R01AG062401-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10394221. Licensed CC0.

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